Senator Lautenberg’s bill “Safe Chemical Act of 2010” sets up a whole new regime for both manufacturers and processors of chemicals that outreaches REACH.
Companies must prove their chemicals and uses are “safe” by providing a minimum data set along with any other data EPA says it wants. EPA may issue by order any restrictions on new chemicals and new uses as it makes findings on “safety standards.” The new “burden of proof” regime.
EPA is mandated to list “priority” existing chemicals and issue “safety standards” – conditions under which chemicals may be made or used. Once listed, manufacturers and processors have 30 months to submit a data package to EPA to prove their chemicals and uses are safe. EPA has to be satisfied the chemical and use(s) meet the to-be-developed safety standard. If EPA hasn’t completed a safety standard within 180 days, companies must inform everyone that the standard is pending. All chemicals must have a minimum data set within 14 years.
The Senate bill does not define “safe.” It does offer a definition not used elsewhere (though it appears in the House discussion draft) for “reasonable certainty of no harm” – which covers cumulative exposures and negligible risk to vulnerable populations. (Is anything safe? It might be easier for EPA to list what meets this standard and ban everything else.)
EPA is also supposed to come up with “Hot Spots” around the country with “disproportionate” exposures and develop action plans to reduce risk. The public can petition to add locations.
Pesky notice and comment rulemaking and judicial review seem to be largely eliminated. EPA will operate by issuing orders. E.g., no review for listing priority chemicals or hot spot locations, decisions that a chemical or use doesn’t meet a safety standard, and automatic banning of International convention POP and PIC chemicals.
All collected information is to be published on the Internet, with limited confidentiality claims allowed, and EPA is to be “transparent” in its decision-making.
The bill is basically SNURs (Significant New Use Rules) on steroids. WAKE UP PROCESSORS – companies who use chemicals to make products – you will be consumed by this proposed law. You will be reporting for the new version of an inventory, paying for data packages, complying with exposure restrictions, and notifying new uses of chemicals.
There will be massive new requirements on companies who aren’t major manufacturers subject to REACH (not that they are going to have a picnic either). There will also be massive requirements on EPA to execute the findings and orders and develop action plans. As both a former company TSCA manager and a former TSCA rule writer, this will be a total nightmare. As a consultant, I’m smiling - this could result in a lot of new business.
More details to come.